Texas OKs experimental stem cell therapy rules

AUSTIN, Texas — The Texas Medical Board on Friday approved new rules on experimental stem cell therapies such as the one Gov. Rick Perry underwent during back surgery last year, despite objections they don't do enough to protect patients and could led to an explosion of doctors promoting unproven, expensive treatments.

The rules require patients to give their consent, and a review board must approve the procedure before doctors use stem cell treatments.

Supporters say establishing formal rules will lead to more medical innovation by opening doors for researchers in Texas. At the same time, board members acknowledged they don't know how many doctors are already performing stem cell procedures, and several who voted in favor said the rules provide the first layers of patient protection.

"We're trying to be safe. It's the wild, wild west right now," said Dr. Scott Holliday, an anesthesiologist from Arlington.

The Food and Drug Administration hasn't approved using adult stem cells to help people heal from surgery, but experimentation is common.

Perry, who appointed the board, had stem cells taken from the fat in his own body that were then grown in a lab. They were injected into his back and his bloodstream during an operation to fuse part of his spine.

Celltex Therapeutics Corp. of Houston, which is co-owned by Dr. Stanley Jones, Perry's friend who performed his operation, supported the rule approved Friday.

Nathan Kottcamp, a Celltex attorney, testified before the board and dismissed predictions of an explosion of new stem cell labs promoting therapies. Harvesting stem cells is a complex, expensive process that cost patients up to $35,000, Kottcamp said.

Texas doctors using stem cell treatments are ethical and trying to help their patients, Kottcamp said.

Jones appeared before the board last year to tout stem cell therapies and said thousands of Americans are going to other countries for treatments. Texans should be able to get care in their home state, he said.

Supporters of the rules said requiring treatments to be approved by review boards is a critical step in favor of patient safety. Boards could be attached to medical schools or hospitals, or be accredited, independent for-profit review boards.

But Leigh Turner, an associate professor at the University of Minnesota's Center for Bioethics & School of Public Health who has complained to federal regulators about Celltex, warned that doctors will be able to "shop around" for a for-profit review board that will give them a favorable ruling.

"(Review board) is not necessarily high-quality review," Turner said.

Texas joins at least 10 other states, including California, Illinois and New York, who have enacted rules governing stem cell research.

Board member Dr. W. Roy Smythe, a surgeon from Temple, voted against the rules, saying they do too little to protect patients or rein in doctors touting unproven treatments.